BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3840436 · Received May 30, 2014

    Report

    Report Number
    3007566237-2014-01480
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 7, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR; LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_ENS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: EXTERNAL NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    DE CARIDI, G., MASSARA M., DAVID, A., GIARDINA, M., LA SPADA, M., STILO, F., SPINELLI, F., GRANDE, R., BUTRICO, L., DE FRANCISCIS, S., SERRA, R. SPINAL CORD STIMULATION TO ACHIEVE WOUND HEALING IN A PRIMARY LOWER LIMB CRITICAL ISCHAEMIA REFERRAL CENTRE. INTERNATIONAL WOUND JOURNAL. 2014. DOI: 10.11 J L/IWJ.12272. SUMMARY: CRITICAL LOWER LIMB ISCHAEMIA IS A DIFFUSE PATHOLOGY THAT COULD CAUSE CLAUDICATION, SEVERE ISCHAEMIC PAIN AND TISSUE LOSS. THE COMMON TREATMENT INCLUDES MODIFICATION OF RISK FACTORS, PHARMACOLOGICAL THERAPY AND ENDOVASCULAR OR SURGICAL REVASCULARISATION OF THE LOWER LIMB TO RESTORE A PULSATILE FLOW DISTALLY. SPINAL CORD STIMULATOR IS SEEN AS A VALID ALTERNATIVE IN PATIENTS UNSUITABLE FOR REVASCULARISATION AFTER ENDOVASCULAR OR SURGICAL REVASCULARISATION FAILURE AND AS ADJUVANT THERAPY IN THE PRESENCE OF A FUNCTIONING BYPASS IN PATIENTS WITH EXTENSIVE TISSUE LOSS AND GANGRENE PRESENTING A SLOW AND DIFFICULT WOUND HEALING. WE REPORT OUR EXPERIENCE ON SPINAL CORD STIMULATION (SCS) INDICATION AND IMPLANTATION IN PATIENTS WITH CRITICAL LOWER LIMB ISCHAEMIA, AT A HIGH-VOLUME CENTRE FOR THE TREATMENT OF PERIPHERAL ARTERIAL DISEASE. REPORTED EVENTS: ONE PATIENT EXPERIENCED A COMPLETE HEALING OF HIS FOOT LESION, BUT HAD THE SPINAL CORD STIMULATION (SCS) REMOVED DUE TO AN INFECTION SIX MONTHS AFTER IMPLANT. THREE PATIENTS DID NOT SHOW IMPROVEMENT AND HAD THE SCS REMOVED 2, 5, AND 8 MONTHS AFTER IMPLANT DUE TO ¿MALFUNCTION¿ AND ¿FAILURE OF SCS.¿ THE PATIENTS REPORTEDLY THEN UNDERWENT LOWER LIMB AMPUTATION DURING THE FOLLOW-UP. ONE PATIENT HAD THE DEVICE EXPLANTED 2 YEARS AFTER IMPLANT FOR SURGICAL WOUND DEHISCENCE AT THE LEVEL OF THE IMPLANTABLE NEUROSTIMULATOR (INS). ONE PATIENT HAD THE DEVICE EXPLANTED 3 YEARS AFTER IMPLANT FOR SURGICAL WOUND DEHISCENCE AT THE SITE OF LEADS PLACEMENT FOR A WOUND ON THE BACK. TWO PATIENTS HAD THE TEMPORARY SPINAL CORD STIMULATORS EXPLANTED THREE WEEKS AFTER IMPLANTATION DUE TO A LOCAL INFECTION. THE REPORTER STATED THAT THESE PATIENTS LATER UNDERWENT LOWER LIMB AMPUTATION. TWO PATIENTS HAD THE TEMPORARY SPINAL CORD STIMULATORS EXPLANTED DUE TO MALFUNCTION AND PERSISTENCE OF SYMPTOMS AND PERSISTENCE OF PAIN TWO WEEKS AFTER IMPLANT. THE REPORTER STATED THAT THESE PATIENTS LATER UNDERWENT LOWER LIMB AMPUTATION. THE SOURCE LITERATURE DID NOT INCLUDE ANY SPECIFIC DEVICE INFORMATION. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318709 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Required Intervention